Jill Wechsler, ACT's Washington Correspondent

There is a critical need to rethink standards of evidence and of the reliability of information used to make regulatory decisions. According to the FDA, this involves placing greater reliance on data from sources outside traditional clinical studies and because of these new tools for collecting the data, the FDA needs to adapt as well.

The National Institutes of Health (NIH) focuses on developing strategies that will encourage further research to support safe and effective therapies for pregnant and lactating women.

The agency is encouraging drug companies to adopt innovative research methods and development tools-and showing more flexibility in approving therapies that have taken non-conventional paths.

With the rise in deaths, injuries, and treatment costs related to the abuse and misuse of opioid painkillers, the biomedical research community is seeking more effective and informative methods for testing and evaluating new pain medicines. Jill Wechsler reports.

Jill Wechsler discusses the importance of clinical trial participants and the challenges FDA faces in expanding patient engagement.

The FDA ruling that exempts biosimilar makers from waiting an extra six months after approval to distribute a new product should help overcome delays in future biosimilar sales, writes Jill Wechsler.

With the new FDA commissioner officially in, the FDA begins the considerable task of implementing key "Cures" initiatives.

Policy makers, sponsors and regulators are taking steps to promote alternative study formats and methods that go beyond randomized clinical trials.

The Senate confirms Scott Gottlieb as FDA commissioner. User fee reauthorizations, a hiring freeze, and the opioid epidemic are a few of the issues awaiting the agency's new leader.

An international panel of industry experts has concluded that randomized, controlled clinical trials provide the fastest and most reliable way to identify the risks and benefits of treatment candidates for infectious disease outbreaks.

At his confirmation hearing before the Senate Health, Education, Labor and Pensions Committee, Scott Gottlieb addressed concerns about the FDA’s future.

The rise of new drugs targeting rare disease ignites increased push for flexible R&D approaches and more collaboration on orphan drug designation and clinical trial design between global regulators.

President Trump’s nomination of Scott Gottlieb as the next FDA Commissioner has given pharma a reason for calm, though a lot will be on his plate.

Pressure from the FDA and Congress has resulted in sponsors enrolling more women, elderly and ethnically diverse individuals in clinical studies.

FDA bioresearch monitoring staffs are being prompted to update and refine systems for targeting inspections to key study sites.

The latest version of the Prescription Drug User Fee Act has sponsors and FDA officials pressing for Congressional action regarding the program’s provisions accelerating the drug development and application review processes.

The needed resources to implement "Cures" legislation makes it critical that user fee programs for drugs are reauthorized well before they expire on Sept. 30.

The FDA has released a report that documents the value of large, confirmatory Phase III studies in ensuring the safety and efficacy of experimental medical products.

The FDA’s Office of Regional Affairs will look to implement their much-anticipated Program Alignment initiative, thus reorganizing the FDA field force in 2017. This new program will alter bioresearch monitoring of clinical research operations.

A revised version of the Common Rule will remove the need for additional informed consent when studying biospecimen data of clinical trial participants.

Congress took a major step yesterday towards shoring up FDA operations and biomedical research supported by the National Institutes of Health with House passage of the 21st Century Cures bill.

With a new administration in Washington, sponsors and regulators are weighing several initiatives that promise to reshape clinical research policies.

FDA officials agree that large comparative clinical trials defeat the purpose of the abbreviated development program for biosimilars. Clinical testing is expected to gain market approval for most biosimilars, while emphasizing significant differences in developing biosimilars and innovator therapies.

The FDA approved Sarepta’s Exondys for Duchenne muscular dystrophy despite little evidence of efficacy, leading many to regard the decision as not being a model for future drug development. The challenge now is to see if confirmatory trials show more benefit, or lack of efficacy.

The deadline looms for new FDA requirements that all applications for new drugs and biologics compile and submit clinical trial data electronically. Meanwhile, efforts by the Clinical Data Interchange Standards Consortium (CDISC) to develop consensus-based standards for collecting data are not going unnoticed.

FDA and industry have agreed on a set of recommendations for revising the drug user fee program, which now sits before Congress as U.S. election nears.

After months of debate, clinical research activity regulated or funded by the government must adhere to revised guidelines regarding transparency. A final rule published by the Department of Health and Human Services states that all beyond Phase I FDA regulated and NIH funded clinical trials must comply with the new requirements.

The way the Open Payments system is couching investigator transactions is questionable and confusing.

The need to revise the design, performance and interpretation of clinical research to reflect changing methods and standards is drawing increased attention.

FDA's breakthrough drug initiative has proven successful to date, but challenges remain in addressing the expectations and patient concerns surrounding candidates in this program.